The Galmaz Biotech® SIROCCO™ Thermal Regulating System is intended to prevent and treat hypothermia and provide warmth to cold or shivering patients. In addition, the Galmaz Biotech® SIROCCO™ Thermal Regulating System should be used whenever conditions exist that could cause patients to become cold.

Device Description

The Sirocco™ temperature management system consists of a portable forced-air temperature management unit and a disposable forced-air blanket (various models).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ""Sirocco™ Thermal Regulating System"":

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report with specific acceptance criteria and performance metrics. Therefore, much of the requested information (especially quantitative performance data, sample sizes for training/test sets, expert qualifications, and detailed ground truth methodology) is not present in this document. The document primarily relies on non-clinical testing and comparison to existing, legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Safety Standards
IEC 60601-1:1993 + A1:1996 + A2:1996 + A2:1999 ERRATUM + A13:1997 (Electronic Medical Equipment: General requirements for safety)	Complied with standard
IEC 60601-1-2:2002 +A1:2006 (Electronic Medical Equipment: Electromagnetic compatibility)	Complied with standard
IEC 60601-1-4:1997 +A1:2000 (Electronic Medical Equipment: Programmable Electronic Medical systems)	Complied with standard
UL 60601-1:2002 (Medical Electrical Equipment: General Requirements for Safety)	Complied with standard
IEC ISO 10993-1:2004 (Biological sterile product evaluation)	Complied with standard
IEC ISO 10993-7: 1996 (Biological evaluation of sterile products: Remainders in sterilization by ethylene oxide)	Complied with standard
Internal Tests
Initial Test of operation of electronic plates according to INS-B-001	Successful
Final assembly INS-B-001	Successful
Final verification of assembled product INS-B-002	Successful
Visual Inspection	Successful
Test of operation of alarms and security systems	Successful
Pressure Test	Successful
Temperature Test	Successful
Electrical Safety Test	Successful
Final Test	Successful
Final labeling of the equipment INS-B-003	Successful
Final packaging of the equipment INS-B-004	Successful
Substantial Equivalence
Similar technological characteristics to predicate devices (Augustine Medical, Inc. Bair Hugger Model 750 and 505)	Achieved
Same intended use as predicate devices	Achieved

Explanation of the Study and Data:

The "study" presented here is a demonstration of substantial equivalence through non-clinical testing rather than a clinical trial with specific performance endpoints for accuracy, sensitivity, or specificity against ground truth in a patient population.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified. The document refers to "studies conducted on the sterile disposable Sirocco™ Thermal Regulating System forced-air blanket" and "internal tests" of the warming unit in general. Specific sample sizes for these tests (e.g., number of blankets tested, number of units tested) are not provided.
Data Provenance: The tests described are primarily bench/laboratory tests conducted internally by Galmaz Biotech S.L. and against recognized international safety and performance standards. There is no mention of patient data (retrospective or prospective) being used for this submission. The country of origin for the testing would presumably be where Galmaz Biotech S.L. operates (implied to be Spain based on other documents related to this company, though not explicitly stated in this text).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Number of Experts: Not applicable/not specified. The grounding for this device's safety and effectiveness relies on adherence to established technical standards and internal quality control tests. There is no mention of experts establishing "ground truth" in the diagnostic or clinical sense for a test set.
Qualifications of Experts: Not applicable/not specified.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. Since there's no "ground truth" derived from expert consensus on patient data, there's no adjudication method in the context of clinical performance evaluation described. The "adjudication" for the non-clinical tests would be the pass/fail criteria for each standard and internal test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a thermal regulating system, not an imaging or diagnostic AI device where human reader performance would typically be measured.
Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study was conducted or relevant to this type of device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Standalone Study: Yes, in a sense, the non-clinical tests can be viewed as a "standalone" evaluation of the device's technical performance against established engineering and safety standards. The device's operation (e.g., temperature regulation, alarm function) is assessed directly. However, this is not a "standalone algorithm" in the context of AI-driven diagnostic tools.

7. Type of Ground Truth Used:

Type of Ground Truth: The "ground truth" for this device's submission is primarily based on:
- Regulatory Standards: Adherence to established international and national standards for medical electrical equipment safety, electromagnetic compatibility, biological evaluation, etc. (e.g., IEC 60601 series, ISO 10993 series, UL 60601-1).
- Internal Specifications: The device's performance against its own design specifications and quality control procedures (e.g., INS-B-001, INS-B-002, INS-B-003, INS-B-004 for electronic plates, assembly, verification, labeling, packaging; and tests for alarms, pressure, temperature, electrical safety, visual inspection).
- Predicate Device Characteristics: The functional and technological characteristics of the legally marketed predicate devices are used as a benchmark for "substantial equivalence."

8. Sample Size for the Training Set:

Sample Size for Training Set: Not applicable/not mentioned. This device does not appear to use machine learning or AI that would require a "training set" in the conventional sense. The "training" of the manufacturing process and design would be based on engineering principles and quality management systems.

9. How the Ground Truth for the Training Set Was Established:

How Ground Truth for Training Set Was Established: Not applicable. Given no AI/ML component relevant to "training data," this question doesn't apply. The design and manufacturing process are validated against engineering principles and regulatory requirements.

Summary

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JUN 3 0 2011

5.0 SMDA Summary

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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The assigned 510(k) number is:

1. Name of Submiter:

Chris Zander Director of North American Operations 1064 Labarge Rd Hudson, WI 54016-7340

2. Device Name:

Device Proprietary / Trade Name: Sirocco™ Thermal Regulating System

Common Name:	Hyper/Hypothermia system
Classification Names:	System, Thermal regulatory
Device Classification:	Class II
Regulation Number:	21 CFR 870.5900
Product Codes:	DWJ

3. Legally Marketed Equivalent Device Name:

We are claiming substantial equivalence to:

Augustine Medical, Inc. Bair Hugger Model 750 unit used with Bair Hugger blankets; . K001149
. Augustine Medical, Inc. Bair Hugger Model 505 unit used with Bair Hugger blankets; K960167

4. Description of the Device:

The Sirocco™ temperature management system consists of a portable forced-air temperature management unit and a disposable forced-air blanket (various models).

Galmaz Biotech S.L.

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5. Intended Use of the Device:

The Galmaz Biotech® SIROCCO™ Thermal Requlating System is intended to prevent and treat hypothermia and provide warmth to cold or shivering patients. In addition, the Galmaz Biotech® SIROCCO™ Thermal Regulating System should be used whenever conditions exist that could cause patients to become cold.

6. Comparison of technological characteristics With Predicate Device:

The Sirocco™ Thermal Requlating System is substantially equivalent in its technological characteristics as the predicate devices.

Augustine Medical, Inc. Bair Hugger Model 750 unit used with Bair Hugger blankets; . K001149
Augustine Medical, Inc. Bair Hugger Model 505 unit used with Bair Hugger blankets; . K960167

7. Discussion of Non clinical Studies:

Results of studies conducted on the sterile disposable Sirocco™ Thermal Regulating System forced-air blanket demonstrate the device is substantially equivalent in safety and effectiveness with the predicate devices.

In addition, the following standards and internal tests were conducted to ensure the safety of the user and patient.

STANDARDS	WARMING UNIT
IEC 60601-1:1993+ A1:1996+ A2:1996+ A2:1999 ERRATUM+ A13:1997	Electronic Medical Equipment. Part 1: General requirements for safety
IEC 60601-1-2:2002+A1:2006	Electronic Medical Equipment. Part 1-2: General requirements for the security. Collateralnorm: Electromagnetic compatibility. Requirements and tests (IEC 60601-1-2: 2001/A1:2004
IEC 60601-1-4:1997+A1:2000	Electronic Medical Equipment. Part 1: General requirements for the security. 4: Collateralnorm: Programmable Electronic Medical systems
UL 60601-1:2002	Medical Electrical Equipment, Part 1: General Requirements for Safety
IEC ISO 10993-1:2004	Biological sterile product evaluation. Part 1: Evaluation and tests.
IEC ISO 10993-7: 1996	Biological evaluation of sterile products. Part 7: Remainders in sterilization by ethyleneoxide.

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INTERNALTESTS	DESCRIPTION
01	Initial Test of operation of electronic plates according to INS-B-001
02	Final assembly INS-B-001
03	Final verification of assembled product INS-B-002
03	Visual Inspection
03	Test of operation of alarms and security systems
03	Pressure Test
03	Temperature Test
03	Electrical Safety Test
03	Final Test
04	Final labeling of the equipment INS-B-003
05	Final packaging of the equipment INS-B-004

8. Conclusion:

r -. . The GALMAZ BIOTECH® Sirocco™ Thermal Regulating System has similar technological characteristics and the same intended use as devices currently on the market.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room –WO66-G609 Silver Spring, MD 20993-0002

JUNY 3- 0 - 2011

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Galmaz Biotech S.L. c/o Mark Job Regulatory Technology Services, LLC 1394 25th St. NW Buffalo, MN 55313

Re: K102856

SIROCCO™ Patient Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: June 15, 2011 Received: June 16, 2011

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilisting of devices; good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Mark Job

CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4.0 INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Sirocco™ Thermal Regulating System.

Indications for Use:

The Galmaz Biotech® SIROCCO™ Thermal Regulating System is intended to prevent and treat hypothermia and provide warmth to cold or shivering patients. In addition, the Galmaz Biotech SIROCCO™ Thermal Regulating System should be used whenever conditions exist that could cause patients to become cold.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign)

Olvision Sign-Off) Division of Cardiovascular Devices

510(k) Number

Regulation Number and Section

§ 870.5900 Thermal regulating system.

(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).